Why the World Needs Bioethics Communication.

This essay argues for the importance of formalizing public engagement efforts around bioethics as something we might call "bioethics communication," and it outlines the Johns Hopkins Berman Institute of Bioethics' plans for engaging in this effort. Because science is complex and difficult to explain to nonexperts, the field of science communication has arisen to meet this need. The field involves both a practice and a subject of empirical research. Like science, bioethics is also complex and difficult to explain, which is why the world needs bioethics communication. The authors are engaged in a brand-new effort to establish the sort of public bioethics efforts that would constitute bioethics communication, through a program which they call the Dracopoulos-Bloomberg iDeas Lab. The authors invite colleagues to experiment and learn with them as they invest in the development of bioethics communicators and their products.

Research led by participants: a new social contract for a new kind of research.

In recent years, there have been prominent calls for a new social contract that accords a more central role to citizens in health research. Typically, this has been understood as citizens and patients having a greater voice and role within the standard research enterprise. Beyond this, however, it is important that the renegotiated contract specifically addresses the oversight of a new, path-breaking approach to health research: participant-led research. In light of the momentum behind participant-led research and its potential to advance health knowledge by challenging and complementing traditional research, it is vital for all stakeholders to work together in securing the conditions that will enable it to flourish.

Paranoid delusional disorder follows social anxiety disorder in a long-term case series: evolutionary perspective.

Social anxiety disorder (SAD) patients may have self-referential ideas and share other cognitive processes with paranoid delusional disorder (PDD) patients. From an evolutionary perspective, SAD may derive from biologically instinctive social hierarchy ranking, thus causing an assumption of inferior social rank, and thus prompting concerns about mistreatment from those of perceived higher rank. This naturalistic longitudinal study followed four patients with initial SAD and later onset of PDD. These four patients show the same sequence of diagnosed SAD followed by diagnosed PDD, as is often retrospectively described by other PDD patients. Although antipsychotic medication improved psychotic symptoms in all patients, those who also had adjunctive serotonin-specific reuptake inhibitors for SAD had much more improvement in both psychosis and social functioning. From an evolutionary perspective, it can be conjectured that when conscious modulation of the SAD social rank instinct is diminished due to hypofrontality (common to many psychotic disorders), then unmodulated SAD can lead to paranoid delusional disorder, with prominent ideas of reference. Non-psychotic SAD may be prodromal or causal for PDD.

Managing incidental findings and research results in genomic research involving biobanks and archived data sets.

Biobanks and archived data sets collecting samples and data have become crucial engines of genetic and genomic research. Unresolved, however, is what responsibilities biobanks should shoulder to manage incidental findings and individual research results of potential health, reproductive, or personal importance to individual contributors (using "biobank" here to refer both to collections of samples and collections of data). This article reports recommendations from a 2-year project funded by the National Institutes of Health. We analyze the responsibilities involved in managing the return of incidental findings and individual research results in a biobank research system (primary research or collection sites, the biobank itself, and secondary research sites). We suggest that biobanks shoulder significant responsibility for seeing that the biobank research system addresses the return question explicitly. When reidentification of individual contributors is possible, the biobank should work to enable the biobank research system to discharge four core responsibilities to (1) clarify the criteria for evaluating findings and the roster of returnable findings, (2) analyze a particular finding in relation to this, (3) reidentify the individual contributor, and (4) recontact the contributor to offer the finding. We suggest that findings that are analytically valid, reveal an established and substantial risk of a serious health condition, and are clinically actionable should generally be offered to consenting contributors. This article specifies 10 concrete recommendations, addressing new biobanks as well as those already in existence.

Decisions about life-sustaining measures in children: in whose best interests?

UNLABELLED: As the community of physicians and nurses dedicated to the care of critically ill children has gained ever more well-developed skill sets, the decision to either continue or forego life-sustaining measures has become less time-sensitive. As a result, there is greater opportunity for careful consideration and discussion. The core principle in making decisions about whether to continue or forego life-sustaining measures is the best interests of the child. However, there are many clinical situations wherein factors other than the child's best interests may influence treatment decisions. The present report seeks to examine the notion that in the arena of paediatric critical care medicine, the decision-making process regarding life-sustaining measures may place insufficient priority upon the child's best interests. We examine actual, de-identified clinical situations, encountered in the critical care arena in two categories: (i) cases that challenge the imperative to act in the child's best interests, and (ii) cases that compromise the ability of parents and caregivers to use child-centred, best-interests approaches to decision-making. Clarity surrounding the implications of a clinical decision for the patient is essential. Decisions that are not focused squarely on the child's best interests may compromise the delivery of optimally ethical end-of-life care. CONCLUSION: The cases and analysis may benefit parents and caregivers as they struggle with the difficult ethical issues that accompany decisions to continue or forego life-sustaining measures in children.

Operational Recommendations for Scarce Resource Allocation in a Public Health Crisis.

The coronavirus disease 2019 pandemic may require rationing of various medical resources if demand exceeds supply. Theoretical frameworks for resource allocation have provided much needed ethical guidance, but hospitals still need to address objective practicalities and legal vetting to operationalize scarce resource allocation schemata. To develop operational scarce resource allocation processes for public health catastrophes, including the coronavirus disease 2019 pandemic, five health systems in Maryland formed a consortium-with diverse expertise and representation-representing more than half of all hospitals in the state. Our efforts built on a prior statewide community engagement process that determined the values and moral reference points of citizens and health-care professionals regarding the allocation of ventilators during a public health catastrophe. Through a partnership of health systems, we developed a scarce resource allocation framework informed by citizens' values and by general expert consensus. Allocation schema for mechanical ventilators, ICU resources, blood components, novel therapeutics, extracorporeal membrane oxygenation, and renal replacement therapies were developed. Creating operational algorithms for each resource posed unique challenges; each resource's varying nature and underlying data on benefit prevented any single algorithm from being universally applicable. The development of scarce resource allocation processes must be iterative, legally vetted, and tested. We offer our processes to assist other regions that may be faced with the challenge of rationing health-care resources during public health catastrophes.

Genomics in the era of COVID-19: ethical implications for clinical practice and public health.

Genomic studies of patients with COVID-19, or exposed to it, are underway to delineate host factors associated with variability in susceptibility, infectivity, and disease severity. Here, we highlight the ethical implications-both potential benefits and harms-of genomics for clinical practice and public health in the era of COVID-19.

Managing incidental findings in human subjects research: analysis and recommendations.

No consensus yet exists on how to handle incidental findings (IFs) in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are findings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed.

Early trauma, attachment experiences and comorbidities in schizophrenia.

OBJECTIVE: To evaluate attachment patterns in subjects with schizophrenia and their relationships to early traumatic events, psychotic symptoms and comorbidities. METHODS: Twenty patients diagnosed with schizophrenia according to criteria from the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) underwent retrospective symptom assessment and careful assessment of the number and manner of childhood caregiver changes. The Diagnostic Interview for Psychosis and Affective Disorders (DI-PAD) was used to assess symptoms related to schizophrenia (positive and negative symptoms), depression and mania. Anxiety disorder comorbidities were assessed by the Liebowitz Social Anxiety Scale (LSAS), Yale-Brown Obsessions and Compulsions Scale (Y-BOCS) and Panic and Schizophrenia Interview (PaSI). Experience in Close Relationships - Relationship Structures (ECR-RS) and Early Trauma Inventory Self Report-Short Form (ETISR-SF) were used to assess attachment patterns and traumatic history, respectively. RESULTS: Moderate and significant correlations between attachment patterns and early trauma showed that greater severity of anxious attachment was predicted by a higher frequency of total early traumas (Spearman ρ = 0.446, p = 0.04), mainly general traumas (ρ = 0.526, p = 0.017; including parental illness and separation, as well as natural disaster and serious accidents). Among the correlations between early trauma and comorbid symptoms, panic attacks occurring before the onset of schizophrenia showed significant and positive correlations with ETISR-SF total scores and the sexual trauma subscale. CONCLUSION: Children with an unstable early emotional life are more vulnerable to the development of psychopathology, such as panic anxiety symptoms. Traumatic events may also predict later schizophrenia.

Beyond disclosure: the necessity of trust in biomedical research.

Biomedical research is experiencing a crisis in public trust. Although the vast majority of clinical studies are conducted in an ethical fashion, public perceptions are fueled by well-publicized examples of unethical practices. Mistrust is further encouraged by the duality of the role of the clinical researcher, who is charged with both caring for patients and answering a research question. Disclosure is not adequate to fully address conflicts of interest in biomedical research; instead, efforts to protect patients' interests and enhance trust should combine disclosure with an attempt to reduce conflicts in the first place as much as possible.

Genetic testing and the future of disability insurance: ethics, law & policy.

Predictive genetic testing poses fundamental questions for disability insurance, a crucial resource funding basic needs when disability prevents income from work. This article, from an NIH-funded project, presents the first indepth analysis of the challenging issues: Should disability insurers be permitted to consider genetics and exclude predicted disability? May disabilities with a recognized genetic basis be excluded from coverage as pre-existing conditions? How can we assure that private insurers writing individual and group policies, employers, and public insurers deal competently and appropriately with genetic testing?

Schizophrenia dissection by five anxiety and depressive subtype comorbidities: Clinical implications and evolutionary perspective.

Twenty patients with DSM5 schizophrenia were comprehensively and formally assessed by an experienced psychiatrist. All subjects were assessed for: positive and negative psychotic symptoms; social anxiety; panic anxiety; obsessive compulsive disorder, atypical depression; major depression; suicide risk; and global assessment of functioning. Different profiles of clinical presentation and symptom evolution emerged for patients with schizophrenia who had co-morbid depression (15%), OCD (15%), panic or limited symptom attacks (55%) and social anxiety (5%). At least eighty percent of the sample had one or more of these co-morbidities. Summing up, the data support our previous finding that panic is highly prevalent in Schizophrenia with Auditory Hallucinations (>73% here, versus 100% before), and panic was paroxysmally concurrent with voice onset. Moreover, characteristic clinical findings may help point clinicians to five specific co-morbidity psychosis subtypes. Moreover, co-morbidity dissection of psychotic diagnoses recalls and parallels the historical psychopharmacologic dissection of non-psychotic anxiety and depressive subtypes diagnoses. Larger studies should further test and explore these preliminary findings.